Director Facilities and Engineering

Job Title: Director, Facilities and Engineering

Reports To: Chief Operating Officer

Classification: Exempt

Location
:
In-person – Berkeley and Richmond, CA

Summary

GNI Group is a diversified life sciences company with operating divisions including Berkeley Advanced Biomaterials (BAB) and Berkeley Biologics (BB), focused on the development, manufacturing, and commercialization of innovative biomaterials and biologics supporting surgical, orthopedic, and regenerative medicine applications.

The Director, Facilities & Engineering will provide enterprise leadership and operational oversight of all facility operations, engineering infrastructure, capital planning, utilities, environmental controls, and EHS&S across GNI Biomaterials’ Berkeley and Richmond sites.

This role is responsible for ensuring reliable, compliant, and scalable infrastructure that supports regulated tissue processing, biomaterials manufacturing, quality laboratories, and corporate operations. The Director will lead both short-term operational execution and long-term infrastructure strategy, ensuring that facility capability enables growth, margin improvement, and inspection readiness.

This is a hands‑on operational leadership role in a regulated life sciences manufacturing environment.

Essential Duties and Responsibilities

Enterprise Facilities Strategy & Capital Planning

• Develop and execute short- and long-term facility and engineering strategies aligned with company growth and portfolio expansion.
• Lead annual capital planning and multi-year infrastructure forecasting.
• Establish a disciplined capital portfolio process for facility upgrades, cleanroom expansion, equipment replacement, and utility modernization.
• Ensure capital projects are delivered on‑time, on‑budget, and aligned with manufacturing priorities.
• Evaluate space utilization and long-term real estate strategy across Berkeley and Richmond.

Facility Operations & Infrastructure Reliability

• Oversee day‑to‑day operations of ISO‑classified clean rooms, HVAC systems, utilities, backup power and redundancy systems, environmental monitoring systems.
• Ensure 100% operational support for manufacturing, quality control laboratories, tissue processing operations, corporate functions.
• Develop and enforce preventative and predictive maintenance programs.
• Maintain equipment reliability standards and minimize operational downtime.

Engineering & Technical Services

• Lead corporate engineering projects across manufacturing and lab environments.
• Manage external engineering firms, contractors, and design partners.
• Oversee equipment calibration and maintenance programs.
• Ensure building management systems (BMS) are functioning properly and compliant.
• Support manufacturing process improvements from an engineering perspective.
• Standardize best practices across sites.

Environmental Health, Safety & Security (EHS&S)

• Lead and develop EH&S programs across both sites.
• Ensure compliance with:
• OSHA
• Environmental regulations
• FDA and AATB requirements
• Local and state building and safety codes
• Develop proactive safety culture and training programs.
• Oversee emergency preparedness and response planning.
• Maintain compliant documentation and inspection readiness.

Regulatory & Inspection Readiness Support

• Ensure facility systems meet requirements for FDA inspections, ISO 13485 audits and AATB inspections.
• Ensure documentation for utilities, calibration, and maintenance is inspection‑ready.
• Partner with Quality and Regulatory to ensure facility infrastructure supports compliance

Manufacturing & Cross‑Functional Partnership

• Collaborate closely with manufacturing leadership, supply chain, quality, regulatory, program management and executive leadership.
• Align infrastructure capacity with production scaling plans.
• Support new product introductions with facility readiness planning.
• Ensure facility constraints do not become bottlenecks to portfolio execution.
• Manage landlord relationships and site lease obligations.
• Oversee space planning, renovations, and facility expansions.
• Coordinate site services including:
• Pest control
• Security systems
• Ensure non‑production infrastructure (office space, employee areas) is safe and functional.

Qualifications

• BS in Engineering…